FDA 510(k) Application Details - K000851

Device Classification Name	Enzyme Immunoassay, Opiates   More FDA Info for this Device
510(K) Number	K000851
Device Name	Enzyme Immunoassay, Opiates
Applicant	PSYCHEMEDICS CORP. 1280 MASSACHUSETTS AVE. SUITE 200 CAMBRIDGE, MA 02138 US Other 510(k) Applications for this Company
Contact	WILLIAM THISTLE Other 510(k) Applications for this Contact
Regulation Number	862.3650   More FDA Info for this Regulation Number
Classification Product Code	DJG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/15/2000
Decision Date	12/11/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review